NILANDRON (nilutamide) RATIONALE FOR INCLUSION IN PA PROGRAM Background Nilandron (nilutamide) is used as a combination agent with surgical castration for the treatment of metastatic prostate cancer. Nilandron is an orally active antiandrogen drug that works by blocking the effects of testosterone at the androgen receptor level thereby preventing an androgenic response. Nilandron interrupts the effect that testosterone has on the prostate and deprives it of signals typically responsible for growth and cell differentiation in the prostate (1). Regulatory Status FDA-approved indication: Nilandron is for use in combination with surgical castration for the treatment of metastatic prostate cancer. For maximum benefit, Nilandron treatment must begin on the same day as or on the day after surgical castration (1). Nilandron is contraindicated in patients with severe hepatic impairment and patients should have a baseline liver enzymes test prior to initiation of therapy. Nilandron is also contraindicated in patients with severe respiratory insufficiency (1). Nilandron carries a black box warning for the risk of interstitial pneumonitis, which can lead to hospitalization and death (1). It is not known whether Nilandron can cause fetal harm when administered to a pregnant woman (1). The safety and effectiveness of Nilandron in pediatric patients less than 18 years of age have not been established (1). Summary Nilandron (nilutamide) is an orally active antiandrogen indicated for the treatment of metastatic prostate cancer with surgical castration. Nilandron is only indicated for use in men and should not be used in patients with severe respiratory insufficiency or in patients with a history of liver dysfunction or elevated liver enzymes. The safety and efficacy of Nilandron in Nilandron FEP Clinical Rationale NILANDRON (nilutamide) pediatric patients less than 18 years of age have not been studied (1). Prior approval is required to ensure the safe, clinically appropriate and cost-effective use of Nilandron while maintaining optimal therapeutic outcomes. References 1. Nilandron [package insert]. St. Michael, Barbados: Concordia Pharmaceuticals Inc.; January 2020. 2. NCCN Clinical Practice Guidelines in Oncology® Prostate Cancer (Version 2.2021). National Comprehensive Cancer Network, Inc. February 2021. Accessed on May 4, 2021. Nilandron FEP Clinical Rationale .